BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL GAS FLOWMETER

    MDR report key: 17624463 · Received August 24, 2023

    Report

    Report Number
    MW5144963
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    August 22, 2023
    Report Date
    August 21, 2023
    Manufacturer
    OHIO MEDICAL LLC
    Product Code
    CAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A BATCH OF 3000 THORPE TUBE FLOWMETERS WITH AMVEX BRAND FROM OHIO MEDICAL INC. WAS FOUND THAT APPROX 200 UNITS FROM THE BATCH ARE SERIOUS FALL OFF THE STANDARD ACCURACY REQUIREMENTS; (B)(4) UNITS ARE AT THE LOWER EDGE OF ACCURACY AND CONSIDER UNCERTAINTY RISK. WHICH RESULT OF 33% NONCONFORMITY PRODUCTS. THE TEST WAS CONTROL ACCORDING TO MANUFACTURER SPECIFICATION. 50PSI INPUT. CALIBRATED DIGITAL FLOWMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726682 MEDICAL GAS FLOWMETER FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED CAX OHIO MEDICAL LLC FM-15UO-F2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention